Abhijeet Kumar
Bengaluru
Summary
Results-driven Clinical Data Management professional with hands-on experience at IQVIA in query management, IRT reconciliation, missing lab reviews, and vendor issue tracking. Proficient in ensuring data accuracy, consistency, and regulatory compliance across global clinical trials. Demonstrates strong understanding of CDM processes, EDC systems, and Good Clinical Practice (GCP). Certified in Ethics Review of Health Research by ICMR. Recognized for delivering high-quality deliverables within timelines, fostering cross-functional collaboration, and contributing to database readiness and data integrity in a fast-paced CRO environment.
Overview
1
1
year of professional experience
2
2
Certifications
Work History
Clinical Data Coordinator
IQVIA
Bengaluru
12.2024 - Current
· Supported end-to-end data cleaning and discrepancy management for global clinical studies, ensuring accuracy and completeness of patient data within timelines.
· Actioned and resolved clinical queries raised during data validation and site review, ensuring consistency with protocol and data-entry guidelines
· Performed IRT (Interactive Response Technology) reconciliation between EDC and vendor systems to maintain data accuracy for randomization, drug dispensation, and subject status tracking.
· Conducted missing lab data review and followed up on discrepancies to support timely database readiness and clean file deliverables.
· Maintained and updated the Vendor Issue Log, coordinating with data specialists and vendors to ensure timely issue resolution.
· Participated in Data Management Team (DMT) reviews to track study progress, identify quality risks, and ensure adherence to data management plans (DMP).
Gained practical exposure to Electronic Data Capture (EDC) systems such as Medidata Rave.
Education
Bachelor of Pharmacy - Pharmacy
Dayananda Sagar University
Bengaluru08-2024
GED -
Catalyst Clinical Services
01-2024
Skills
Query Management
Data Cleaning
Medidata Rave
IRT Reconciliation
Vendor reconciliation
Serious Adverse Event Reconciliation
Excel
Time Management
Attention to detail
Cross-functional Collaboration
Team Management
Certification
National Institute of Drug Abuse
Certificate of Completion- “GOOD CLINICAL PRACTICE”
Certificate of Completion- “GOOD CLINICAL PRACTICE”
Project
Global Phase III Study – Data Cleaning & Query Management
Role: Trainee Clinical Data Coordinator
Tools: Medidata Rave, IRT, Excel
Description:
Supported end-to-end data cleaning activities, including discrepancy management, query generation, and resolution tracking for a global Phase III trial
Conducted daily data reviews and ensured consistency between EDC and source data
Collaborated with data specialists and vendors to ensure timely closure of open queries and database readiness
Contributed to clean file review and audit trail checks before interim data lock
Accomplishments
· Published a Review Article in WEB OF SCIENCE: ISSN 0253-7214
TITLE – Phyto-Pharmacological Effects of Medicinal Plants in Treatment of Depression.
· Selected as a student Placement Coordinator, successfully conducted multiple drives, and coordinated with companies.
· Organized successful events and Fest in College and active member of the college Management Committee.
Languages
English
Proficient (C2)
C2
Hindi
Native
Native
Timeline
Clinical Data Coordinator
IQVIA
12.2024 - Current
Bachelor of Pharmacy - Pharmacy
Dayananda Sagar University
GED -
Catalyst Clinical Services